Kornimate/medical-research-clean huggingface dataset:
the effects of sodium and potassium on blood pressure, vascular function and renal function

Conditions: Hypertension; Blood Pressure; Vascular Function; Renal Function

Summary: to determine the effect of (1) increased sodium intake and (2) increased potassium intake on blood pressure, vascular function and renal function in untreated (pre)hypertensive subjects.

this is a randomized, double-blind, placebo controlled cross-over feeding study.

Eligibility criteria:
inclusion criteria: * (pre)hypertension, defined as office sbp: 130-159 mmhg; * no use of antihypertensive, lipid-lowering, anticoagulant or other cardiovascular medication; * age at start of the ≥ 40 years; * apparently healthy: * no reported current or previous metabolic diseases * no history of cardiovascular diseases * no history of renal, liver or thyroid diseases * no history of gastrointestinal diseases * no diabetes mellitus * fasting laboratory parameters within normal range: renal function (serum creatinine, ureum), liver function (alat, asat, ɣ-gt) and serum glucose. exclusion criteria: * body mass index \> 40 kg/m²; * smoking * secondary hypertension; * weight loss or weight gain of 5 kg or more during the last 2 months; * usage of non-steroidal anti-inflammatory drugs (aspirin, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study. * medical treatment that may affect blood pressure and not able (or willing) to stop taking them; * women taking oral contraceptives or estrogen replacement therapy * taking nutritional supplements and unwilling to discontinue; * women lactating, pregnant or intend to become pregnant during study; * reported dietary habits: medically prescribed diet, slimming diet; * reported alcohol consumption \> 21 units/w (female subjects) or \>28 units/w (male subjects); * unable or unwilling to consume one meal every workday at the university, or to consume the prescribed study diet for 13 weeks; * problems with consuming the supplements or following the study guidelines; * unwilling to undergo home or office blood pressure measurements; * recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period; * reported intense sporting activities \> 10 h/w; * not agreeing to be informed about unexpected and medically relevant personal test-results * participation in another biomedical trial less than 2 months before the start of the study or at the same time; * no informed consent signed.

Keywords: sodium salt potassium blood pressure flow-mediated dilatation endothelial function renal function controlled feeding study dietary intervention
ckd-581 + bortezomib + dexamethasone in patients with previously treated multiple myeloma

Conditions: Myeloma, Multiple

Summary: this study is to determine the maximum tolerated dose(mtd), dose limiting toxicity(dlt), safety and pharmacokinetics(pk) profile of a single agent ckd-581 injection in combination with bortezomib and dexamethasone in patients with previously treated multiple myeloma.

this is an open label, dose escalation study. cohort of 3\~6 patients receive escalation doses of ckd-581 until the maximum toleated dose(mtd) is determined. the mtd is defiend as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Eligibility criteria:
inclusion criteria: * must have received at least one prior lines of therapy and diagnosis of symptomatic multiple myeloma(imwg 2014) * eastern cooperative oncology group performance status ≤ 2 * life expectancy 12 weeks * must have the following laboratory values within 3 weeks prior to first dose of study drug * anc(absolute neutrophil count) ≥ 1,500 mm3 * plt(platelet count)≥ 100,000 mm3 * hb ≥ 8.0g/dl * ast(sgot) and alt (sgpt) ≤ 3 x unl(upper limit of normal) * serum bilirubin ≤ 1.5 x uln (but, gilbert syndrome ≤ 3 x unl) * serum cr ≤ 1.5 x unl * one more measureable disease following values * serum m-protein ≥ 1g/dl * urine m-protein ≥ 200mg/24hr * in that case serum m-protein, urine m-protein nonmeasurable and flc ratio abnormal, serum flc level ≥ 100mg/l(≥10mg/dl) * more than 24 weeks prior to last bortezomib dose * must have signed the consent form exclusion criteria: * patients with central neurological disease * patients with clinically significant heart disease within 24weeks prior to first dose of study drug * patients with clinically significans abnormal ekg, echocardiography at screening * patients with active hepatitis, hiv positive(exception, non active hepatitis) * peripheral neuropathy ≥ ctcae grade 2 or peripheral neuropathy ≥ ctcae grade 1 with pain within 2 weeks prior to first dose of study drug * patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer * patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period * women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. male patients whose sexual partners are not using effective birth control. * patients with hypersensitive reaction of bortezomib or dexamethasone * patients without best overall response is above minimal response based on imwg 2015 past all treatment for multiple myeloma * patients with refractory to past bortezomib treatment(ex; under minimal response) or progress within 60days prior to last bortezomib treatment
necrotizing enterocolities

Conditions: Necrotizing Enterocolitis of Newborn

Summary: haematological disturbances in neonates with necrotizing enterocolities

necrotizing enterocolitis (nec) is an acquired, multifactorial and devastating gastrointestinal disease associated with high morbidity and mortality in preterm neonates. with an incidence of about 7% in infants with bw \&lt; 1500 g and mortality up to 30%, nec presents as a medical and surgical emergency it is characterized by ischemia, necrosis, and inflammation of bowel wall with invasion by gas-forming organisms and intramural dissection of gas ,characteristicall appearing as pneumatosis intestinalis in radiological and pathological studies. while exact etiology is undetermined, the pathogenesis is believed to be an anomalous innate immune response to an altered, less diverse intestinal microbiota by the highly immunoreactive enterocytes of premature infants, leading to inflammation and tissue necrosis * in this devastating disease with undetermined etiology. breast milk feeding, prolonging gestation to avoid prematurity, antenatal steroid, and the use of probiotics/prebiotics are established prevention strategies in nec * the hematological abnormalities associated with nec were first described 25 years ago by hutter et al.the abnormalities observed in a series of 40 patients with nec included thrombocytopenia, with * and without disseminated intravascular coagulation (dic), neutrophilia or neutropenia, and hemolytic anemia.

Eligibility criteria:
inclusion criteria: * preterm less than 36 weeks * or very low birth weight less than 1500 gram exclusion criteria: * full term * normal birth weight ,preterm with early breast feeding or more than 1500 gm
effects of nerve block on knee function after knee replacement

Conditions: Postoperative Pain

Summary: early physical therapy after knee surgery is very painful on top of pain from surgery. pain following surgery can limit recovery. one way to treat pain is by giving intravenous (iv) pain medication with morphine. another method is to use a "nerve block" which involves placing a thin catheter (tube) into the lower back near the nerves that sense pain in the knee and give a local anesthetic to numb the nerves. sometimes both methods are used together. this research is being done to determine whether nerve blocks with a local anesthetic improve knee recovery in addition to providing pain relief as compared to iv pain medicine alone


Eligibility criteria:
inclusion criteria: * age 21-80 year old * asa physical status asa i and ii * mentally competent * intellectually competent * body mass index \<35 * no severe cardiac diseases * no severe pulmonary diseases * unilateral knee disease * no other lower extremity joint disease * no chronic narcotic therapy or illicit drug use exclusion criteria: * age \ 80 year old * asa physical status \>asa ii * mentally incompetent * intellectually incompetent or cognitively impaired * non-english speaking patient * worker's compensation patient * body mass index \> 35 * bilateral knee disease * has other lower extremity joint disease * severe cardiac diseases * severe pulmonary diseases * chronic narcotic therapy or illicit drug use * pregnancy

Keywords: nerve block, postoperative pain, analgesia
vitamin-d receptor in laryngeal squamous cell carcinoma

Conditions: Laryngeal Carcinoma

Summary: laryngeal squamous cell carcinoma (lscc) is the second most common primary malignant tumor of the respiratory tract after lung cancer and the second most common primary epithelial malignant tumor of the head and neck. the age of onset of lscc is mostly between 50 and 70 years, with a male to female ratio of approximately 4:1 .according to estimates by the american cancer society, in the united states, approximately 12,470 new cases of laryngeal cancer will be diagnosed and 3,820 people will die from laryngeal cancer in 2022. the nuclear vitamin d receptor (vdr) is involved in multiple pathways that have many points of convergence. some of these pathways are implicated in carcinogenesis thus the suggestion that vdr has a role to play in the biology of cancer \[3\]. recent evidence indicates that the active form of vitamin d (1alpha, 25-dihydroxycholecalciferol) (vd) exhibits several different effects on normal and cancerous cells, including up-regulation of anti- proliferation and pro-apoptotic factors, as well as inhibition of cell-cycle promoters and growth factor signaling pathways. thus it is useful as an anti-neoplastic agent in several human malignancies. studies in cell and animal model systems, as well as clinical trials have recognized the potential usefulness of vd and vd analogues as agents that enhance the anti-proliferative/cytotoxic effects of chemotherapy and ionizing radiation. thus, at concentrations that produce limited hypercalcemia, these agents may be used as adjuncts to conventional chemotherapy and radiotherapy. we aim to analyze the expression of vdr in lscc to determine potential for active vd therapy in such patients.


Eligibility criteria:
inclusion criteria: 1. both endoscopic and excisional biopsy specimens. 2. all the studied cases include sufficient materials for the immunohistochemical study. 3. complete clinical data exclusion criteria: 1. patients with recurrence of the primary tumor. 2. patients with a history of preoperative chemotherapy and/or radiotherapy. 3. insufficient or tiny tissue biopsies
treatment of hematological malignancy with novel car-t cells.

Conditions: B-cell Non Hodgkin Lymphoma; B-cell Acute Lymphoblastic Leukemia; Multiple Myeloma

Summary: this is a single arm, open-label, early phase i study, to determine the safety and efficacy of novel car-t cell therapy in hematological malignancy treatment.

the novel car-t contains either a scfv plus a pd-l1 blocker, or two scfvs, in a cytokine complex based outer memberane structure, this kind of structure enables the car-t cells to simultaneously target one or two targets on the tumor cell surface and enhance car-t cell persistence in tumor microenvironment，as well as stimulating innate t/nk cell activation and expansion.

Eligibility criteria:
inclusion criteria: 1. all subjects must personally sign and date the consent form before initiating any study specific procedures or activities; 2. all subjects must be able to comply with all the scheduled procedures in the study; 3. clear diagnosis of hematological malignancy, including b-cell non-hodgkin lymphoma, b-cell lymphoblastic leukemia, multiple myeloma. 4. fufill one or more of the following criteria: relapsed after most recent therapy; progressive disease in standard chemotherapy; disease progression or relapsed after asct; 5. at least one clear indicator for hematological malignancy monitoring; 6. aged \<70 years; 7. expected survival ≥12 weeks; 8. eastern cooperative oncology group (ecog) performance status of≤3; 9. systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 10. all other treatment induced adverse events must have been resolved to ≤grade 1; 11. laboratory tests must fulfill the following criteria: anc ≥ 1000/ul, hgb\>70g/l, platelet count ≥ 50,000/ul, creatinine clearance ≤1.5 uln, serum alt/ast ≤2.5 uln, total bilirubin ≤1.5 uln (except in subjects with gilbert's syndrome); exclusion criteria: 1. presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator); 2. patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. the specific selection is ultimately determined by the investigator; 3. lactating women or women of childbearing age who plan to conceive during the investigational time period; 4. active infection with hepatitis b (hbsag positive) or hepatitis c virus (anti-hcv positive); 5. known history of infection with hiv; 6. subjects need systematic usage of corticosteroid; 7. subjects need systematic usage of immunosuppressive drug; 8. planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; 9. other reasons the investigator consider the patient may not be suitable for the study.

Keywords: cd19-tricar-t 1922-tricar-t bcma-tricar-t
extension to a study to assess the efficacy and safety of three doses of vildagliptin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. the purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * only patients successfully completing study claf237a2301 are eligible * written informed consent * ability to comply with all study requirements exclusion criteria: * premature discontinuation from study claf237a2301 * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
intestinal dysbiosis and translocation of bacteria in patients undergoing surgery

Conditions: Surgical Site Infection

Summary: the goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections. the main question this study aims to determine if: * patients undergoing surgery develop transient intestinal dysbiosis * such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection patients undergoing elective abdominal surgery will be included prospectively. informed consent will be obtained. from patients the following information and samples will be collected: * perioperative: baseline health data, nutrition data, measurement body composition, glucose monitoring * intraoperatively: * mucosal swabs * blood from central venous catheter and portal vein * mesenteric lymph node * intestinal specimen * bile * subcutaneous biopsy * postoperatively: * if a surgical site infection occurs samples from infected site


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy. * elective surgery * informed consent * age \> 18 years exclusion criteria: * emergency surgery * other surgery 30 days prior to colorectal surgery * bmi \ 50kg/m2 * planed simultaneous second procedure with involvement of the intestinal tract * cholestasis with cholangitis, hepatic disease (defined as cirrhosis child b or c) or renal disease (acute or chronic renal failure defined as egfr≤ 30ml/min) * severe active enteritis or colitis, malabsorption, enteric infections * pancreatitis
a study of the burden of illness and treatment patterns in teenagers and adults with hereditary angioedema

Conditions: Hereditary Angioedema

Summary: this study is about teenagers and adults with hereditary angioedema (hae) type i and type ii. in this study, the burden of illness means the impact of hae in terms of long-term health outcomes and the financial cost. the main aims of this study are as follows: * to learn how often, how severe and where on the body hae attacks occur. * to describe how hae prophylaxis and on-demand medicines are prescribed and used. (prophylaxis medicines prevent a bleed from happening and on-demand medicines treat a bleed when it occurs.) this study is about collecting data only; participants will not receive treatment as part of this study. existing data available in the participant's medical records will be collected. participants will be asked to complete an electronic questionnaire either on a website or by using an app on their mobile phone; data from this questionnaire will also be collected. participants do not need to visit their doctor in addition to their normal visits.


Eligibility criteria:
inclusion criteria: * participant aged \>= 12 years at the time of the last documented hae attack in the eligibility period. * physician-confirmed diagnosis (or confirmation in medical records) of hae type i or type ii. * participant had at least one documented hae attack during the eligibility period. * participant is not adequately or sub-optimally controlled according to treating physician. * participant (or parent/legal guardian) is willing and able to comply with the study requirements and provides informed consent or assent. exclusion criteria: * participant enrolled in a therapeutic investigational drug or device trial during the observation period. * participant initiated long-term prophylaxis with takhzyro® at any time since diagnosis.
trial evaluating efficacy and safety of dasiglucagon in children with congenital hyperinsulinism

Conditions: Congenital Hyperinsulinism

Summary: the objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (chi) requiring continuous intravenous (iv) glucose administration to prevent/manage hypoglycemia.


Eligibility criteria:
inclusion criteria: * chi diagnosis established based on the following: 1. hyperinsulinemia: plasma insulin above the limit of detection of the assay documented during an event of hypoglycemia, and/or 2. hypofattyacidemia: plasma free fatty acid \<1.7 mmol/l, and/or 3. hypoketonemia: beta-hydroxybutyrate \<1.8 mmol/l, and/or 4. glycemic response: an increase in plasma glucose (pg) of \>30 mg/dl (1.7 mmol/l) after 1 mg iv or intramuscular (im) glucagon administration * male or female, age ≥7 days and \<12 months at screening * body weight of ≥2.0 kg (4.4 lbs.) * continuous iv glucose requirement to prevent hypoglycemia exclusion criteria: * is suspected of having a transient form of chi (e.g., transient hyperinsulinism due to maternal diabetes or perinatal stress) * was born preterm below 34 weeks of gestational age * presence of hypertension or hypotension, including circulatory instability requiring supportive medication or presence of pheochromocytoma * known or suspected presence of severe brain damage * evidence of metabolic, endocrine, or syndromic causes of hypoglycemia not due to hyperinsulinism * use of systemic corticosteroids, e.g., hydrocortisone \>20 mg/m\^2 body surface area or equivalent within 5 days before screening * prior use of lanreotide, sirolimus (mechanistic target of rapamycin \[mtor\] inhibitors), anti-inflammatory biological agents, or other immune modulating agents. prior use of octreotide is allowed after a minimum of 48 hour washout before randomization. * any clinically significant abnormality identified on echocardiogram that in the opinion of the investigator would affect the subject's ability to participate in the trial * any recognized clotting or bleeding disorder * the use of prescription or non-prescription medications known to cause qt prolongation
clinical evaluation of the vedera kxs for the treatment of spherical myopia

Conditions: Myopia

Summary: the objective of this clinical investigation is to evaluate the safety and efficacy of the vedera kxs in sighted eyes for the correction of spherical myopia.


Eligibility criteria:
inclusion criteria: * must be undergoing surgery for the correction of myopia * intended treatment from -0.5 to -6.0 d of spherical myopia * must have 0.50 d or less astigmatic component. * must have bilateral physiologic myopia * bscva of 20/25 or better in each eye * must have had a stable refraction (0.5 d or less change in spheroequivalent) for at least one year, objectively documented (by previous clinical records, eyeglass prescriptions, etc. over one year old) * patients who are contact lens wearers must have hard or gas permeable lenses discontinued for two weeks and soft lenses discontinued for three days prior to the preoperative evaluation * must be at least 18 years of age * corneal topography must be normal, as judged by the investigator * must have a minimal corneal thickness of 475 microns * must sign a written informed consent form acknowledging their awareness of their participation in this study, the alternative treatments available, the risks involved, and the investigative nature of the procedure, and other issues which conform to the standard of care for informed consent practices * must be willing and capable of returning for scheduled follow-up examinations for 24 months after treatment exclusion criteria: * patients who are unable or unwilling to sign the informed consent form. * anterior segment pathology * residual, recurrent or active ocular disease * patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated. * history of herpes keratitis * patients with diagnosed autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications (i.e., corticosteroids or antimetabolites) likely to affect wound healing. * irregular central keratometry/topography readings with irregular topography patterns or keratometry mires, including signs of keratoconus. * patients with known sensitivity to study medications. * intraocular pressure of \> 23 mm hg by goldmann applanation tonometry, a history of glaucoma, or glaucoma suspect. * women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation. * participation in other ophthalmic clinical trials during this clinical investigation.